What are the responsibilities and job description for the Labs Analytical Instrument Qualification (AIQ) Technology Lead position at Maitsys?
Labs Analytical Instrument Qualification (AIQ) Technology Lead
Location: Wilson, NC
We are hiring a Labs Analytical Instrument Qualification (AIQ) Technology Lead for a greenfield manufacturing site implementation project. This role will report into the Quality Control Laboratories organization and will partner closely with QC, IT, Engineering, and vendors to ensure compliant and on‑time instrument qualification.
Lead Responsibilities
- Lead the delivery of Technology components of laboratory capital projects, providing technical, financial, and strategic oversight from concept through implementation
- Own systems analysis and solution design for GxP‑regulated laboratory systems, ensuring compliance with regulatory, data integrity, and cybersecurity requirements
- Lead and manage engagement with third‑party vendors for the provision of laboratory software solutions, ensuring technical fit, regulatory compliance, and value for money.
- Act as a technical and financial authority for laboratory Technology platforms, setting standards, design principles, and investment priorities aligned with enterprise architecture
- Develop and manage capital and operational budgets for laboratory Technology initiatives, ensuring accurate cost estimation, financial control, and value realization
- Drive long‑term technology and investment forecasting for laboratory systems, aligning roadmaps with business strategy, lifecycle planning, and obsolescence management
- Provide senior‑level, on‑demand technical and financial advice to business, quality, and engineering stakeholders, presenting clear, risk‑based options and recommendations
- Partner with Finance, Procurement, and Project teams to support business cases, funding approvals, and vendor cost models
- Ensure alignment between IT, Quality, Engineering, Validation, and external vendors to deliver compliant, cost‑effective solutions
- Partner with IT Infrastructure and Network team to provide IT requirements and collaborate to configure the Labs Instruments to the IT ecosystem.
- Ensure Cyber Security Standards or followed as per company standards and policies
- Support the planning and execution of IOPQ protocols, providing technical input, system configuration support, and issue resolution during qualification activities
- Review and approve system designs, change impacts, risk assessments, and qualification readiness for regulated environments
- Represent the Labs in audits, inspections, and regulatory interactions, confidently defending system architecture, controls, and qualification outcomes
- Mentor and guide junior engineers and project team members, building technical capability, validation awareness, and design consistency
Technical Skills
- Strong understanding of Windows operating systems at both workstation and server levels
- Solid knowledge of networking concepts, including firewall configurations
- Working knowledge of cybersecurity fundamentals and secure system design
- Good understanding of 21 CFR Part 11 requirements and data integrity guidelines in regulated environments
- Strong troubleshooting skills combined with clear communication, escalation management, and decision‑making
- Good understanding of client‑server architecture and client‑server-based solutions used in laboratory environments
- Experience with the implementation of laboratory technologies such as TOC, Endotoxin, UV, and SoloVPE systems would be advantageous.
Soft Skills
- Strong interpersonal skills with the ability to relate well to others
- Excellent oral and written communication skills, with proven ability to communicate and build relationships cross‑functionally
- Confident in presenting technical information in audit and inspection settings
- Able to translate technical concepts into clear, stakeholder‑friendly language